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At least 793 records · Page 44Linked to original sources
PubMed1987

Risks of chorion villus sampling.

From the experience accumulated in less than 4 years of chorionic villus sampling activity, much has been learned about the advantages of prenatal diagnosis in the first trimester. The safety of the procedure during this developmental stage has been extremely good. The record in this centre with over 2700 cases sampled and over 2000 deliveries has demonstrated a fetal loss rate similar to that observed in amniocentesis studies. It appears that fetal loss that may be attributed to the procedure is not more than 1% and may be less. Some of that loss appears to be correlated with avoidable trauma to the chorionic membrane area. If this conclusion is valid, then avoidance of this pattern even in the occasional difficult case may further improve the already acceptable safety record of the procedure.

Biopsy, Needle↗
PubMed2000

Bioequivalence of inhaled formoterol fumarate assessed from pharmacodynamic, safety and urinary pharmacokinetic data.

This paper deals with a crossover trial on healthy volunteers performed to obtain combined pharmacodynamic, safety and pharmacokinetic data in order to assess the bioequivalence of formoterol fumarate (CAS 43229-80-7) delivered by mono-dose dry powder inhalers, as test and reference. The trial was carried out on 24 Caucasian healthy male and female volunteers treated with 12 micrograms formoterol fumarate bihydrate capsules for inhalation route. Pharmacodynamics was evaluated through a challenge test with methacholine on the forced expiratory volume in 1 s (FEV1). Safety was achieved from glucose and potassium serum levels assayed on timed samples over a 12-h period cost-dosing and from blood pressure, heart rate and ECG recording. Pharmacokinetics was obtained from urinary excretion of formoterol, assessed by a highly sensitive analytical method (LC-MS-MS). Pharmacodynamic, safety and pharmacokinetic results evidenced the bioequivalence of the two formulations investigated. This investigation is an interesting approach how to assess bioequivalence when the classical approach based on the similarity of plasma concentrations can not be applied.

Administration, Inhalation↗
PubMed2006

Effectiveness of child safety seats vs seat belts in reducing risk for death in children in passenger vehicle crashes.

OBJECTIVE: To provide an estimate of benefit, if any, of child restraint systems over seat belts alone for children aged from 2 through 6 years. DESIGN: Cohort study. SETTING: A sample of children in US passenger vehicle crashes was obtained from the National Highway Transportation Safety Administration by combining cases involving a fatality from the US Department of Transportation Fatality Analysis Reporting System with a probability sample of cases without a fatality from the National Automotive Sampling System. PARTICIPANTS: Children in tow-away [corrected] crashes occurring between 1998 and 2003. MAIN EXPOSURE: Use of child restraint systems (rear-facing and forward-facing car seats, and shield and belt-positioning booster seats) vs seat belts. Potentially confounding variables included seating position, vehicle type, model year, driver and passenger ages, and driver survival status. MAIN OUTCOMES MEASURE: Death of child passengers from injuries incurred during the crash. RESULTS: Compared with seat belts, child restraints, when not seriously misused (eg, unattached restraint, child restraint system harness not used, 2 children restrained with 1 seat belt) were associated with a 28% reduction in risk for death (relative risk, 0.72; 95% confidence interval, 0.54-0.97) in children aged 2 through 6 years after adjusting for seating position, vehicle type, model year, driver and passenger ages, and driver survival status. When including cases of serious misuse, the effectiveness estimate was slightly lower (21%) (relative risk, 0.79; 95% confidence interval, 0.59-1.05). CONCLUSION: Based on these findings as well as previous epidemiological and biomechanical evidence for child restraint system effectiveness in reducing nonfatal injury risk, efforts should continue to promote use of child restraint systems through improved laws and with education and disbursement programs.

Accidents, Traffic↗
PubMed2006

Investigations on safety of hyperthermic intraoperative intraperitoneal chemotherapy (HIPEC) with Mitomycin C.

AIMS: Previous safety monitoring of hyperthermic intraoperative intraperitoneal chemotherapy (HIPEC) with Mitomycin C (MMC) did not demonstrate any detectable safety hazard to the personnel. Nevertheless, those results have been discussed controversially because of the methodological problems employed in the evaluation of potential exposure. We re-evaluated possible safety hazards of HIPEC by applying different monitoring strategies. METHODS: We monitored air samples in the operation room during HIPEC. In addition, we measured MMC in plasma of the surgeon with a newly developed analytical method. All samples were analysed by HPLC-UV at 360nm. The permeability of the gloves was tested using two in vitro techniques: diffusion cells and a glass cell chamber. In-use and worst-case exposure scenarios were imitated for in vitro experiments. RESULTS: The analysis of the air samples (n=3) could not detect any MMC. We found no drug above the limit of detection (1microg MMC/L) in the plasma samples of the surgeons (n=5). A breakthrough of latex glove material was detected in only one (worst-case exposure scenario) of 40 diffusion cell experiments. CONCLUSIONS: Established methods of safety monitoring could not reveal any detectable risk on in-use exposure conditions. The wearing of doubled latex gloves should prevent the surgeon from dermal exposure to MMC during HIPEC.

Air Pollutants, Occupational↗
PubMed2003

Pharmacokinetic comparison of fast-disintegrating and conventional tablet formulations of risperidone in healthy volunteers.

BACKGROUND: Difficulties with and resistance to tablet-taking are common in all patient groups and can exacerbate compliance problems and undermine treatment efficacy. In recent years, rapidly dissolving oral drug formulations have been developed to overcome problems related to swallowing difficulties. OBJECTIVE: The goal of this study was to evaluate the bioequivalence of a fast-disintegrating oral tablet of risperidone and the conventional oral tablet. METHODS: This was a randomized, open-label, 2-way crossover trial in which healthy volunteers received two 0.5-mg tablets of a fast-disintegrating oral risperidone formulation and two 0.5-mg tablets of conventional oral risperidone, each in a single administration. Blood samples for pharmacokinetic analysis of the active moiety (risperidone + 9-hydroxy-risperidone), risperidone, and its active metabolite 9-hydroxy-risperidone were obtained during a 96-hour period after dosing. Safety assessments included monitoring of adverse events, hematology and biochemistry tests of the sampled blood, urinalysis, blood pressure measurements, and electrocardiography. RESULTS: The bioequivalence assessment was based on pharmacokinetic and statistical analysis of data from 37 subjects who completed both treatment periods. The plasma concentration-time profiles of the active moiety, risperidone, and 9-hydroxy-risperidone were similar after intake of the 2 formulations. The fast-disintegrating tablet and the conventional tablet showed bioequivalence with respect to the active moiety, risperidone, and 9-hydroxy-risperidone. The 90% CIs for the mean treatment ratios of the log-transformed peak plasma concentration, area under the plasma concentration-time curve (AUC) to the last quantifiable time point, and AUC extrapolated to infinity were all within the predefined equivalence range from 80% to 125%. Twenty-eight of 50 (56%) subjects originally randomized reported adverse events, with a similar incidence for both treatments. All adverse events were mild, with somnolence and headache being the most frequently reported. No clinically relevant changes were observed in physical, biochemical, hematologic, or urinalysis variables during the study. CONCLUSION: In this study in healthy subjects, a single administration of two 0.5-mg fast-disintegrating risperidone tablets was bioequivalent to a single administration of two 0.5-mg conventional risperidone tablets.

Adult↗
PubMed2006

[One case report of anti-JK1 antibody undetected on plasma sample].

The sensitivity of the detection of irregular antibodies (DIA) is one of the fundamental bases of transfusion safety. Its implementation is specified in accordance with a very specific framework that allows the use of serum or plasma. The case reported here points out a failure to detect irregular antibodies in plasma sample. Thus a low intensity anti-JK1 antibody detected and identified in serum slipped through unnoticed in plasma. The difficulties to detect and identify this antibody, well-known as a deceptive and dangerous one, are being discussed in order to better assess the limitations of DIA.

Aged, 80 and over↗
PubMed2005

Purification of severe acute respiratory syndrome hyperimmune globulins for intravenous injection from convalescent plasma.

BACKGROUND: Severe acute respiratory syndrome (SARS) is a new infectious disease caused by the SARS virus. Current first-line treatments are experimental, and their effectiveness remains open to question. For more effective treatment and prevention of SARS, human SARS hyperimmune globulins for intravenous (IV) injection were purified in this study. STUDY DESIGN AND METHODS: A combination of cold ethanol precipitation and ion-exchange chromatography was used to process pooled SARS convalescent plasma samples. Virus inactivation and removal approaches were taken to ensure safety. RESULTS: The purified hyperimmune globulins were formulated as a 5 percent solution, with an antibody titer specifically against the SARS virus of 1:83, 1:1600, and 1:200, as determined by enzyme-linked immunosorbent assay, immunofluorescence assay, and neutralizing antibody test, respectively. The purity of the SARS hyperimmune globulins was 99.0 percent, and the monomer and dimer content was 100 percent. Other variables analyzed met the Chinese Requirements of Biologics for IV immune globulin. The SARS hyperimmune globulins prepared were subsequently approved for clinical evaluation by the Chinese National Institute for the Control of Pharmaceutical & Biological Products. CONCLUSION: IV-injectable, purified, and concentrated human SARS hyperimmune globulins were prepared from pooled convalescent plasma samples, which are ready to be further evaluated.

Antibodies, Viral↗
PubMed1998

Field validation of passive monitors for the determination of employee exposures to methylene chloride in pharmaceutical production facilities.

A series of field evaluations was performed to estimate the overall uncertainty of three manufacturers' passive monitors (Assay Technology Model 541 and 546, 3M Model 3520, and SKC Model 575-001) to determine methylene chloride (MeCl2) concentrations. Area samples were exposed in a pharmaceutical production facility at five MeCl2 air concentrations for both permissible exposure limit (PEL) and short-term exposure limit (STEL) periods. A specially designed evaluation chamber was used to concurrently expose six of each type of passive monitor while concurrently collecting six active samples from locations surrounding the dosimeter array. The active samples were used to estimate the actual concentration during the evaluation period. The precision, bias, and overall uncertainty were estimated for each monitor type at concentrations bracketing the Occupational Safety and Health Administration proposed exposure limits. The actual MeCl2 concentrations for the PEL sampling periods ranged from 0.9 to 63 ppm. The pooled overall uncertainty results for all the passive monitors evaluated under PEL sampling conditions met the NIOSH accuracy recommendations. Pooled overall uncertainty for PEL evaluations for the monitors were: Assay Technology Model 546 +/- 17%; 3M +/- 13%; and SKC +/- 17%. Actual MeCl2 concentrations for the STEL sampling periods ranged from 14 to 357 ppm. Pooled overall uncertainty results for Assay Technology and 3M monitors evaluated under STEL sampling conditions met the NIOSH accuracy recommendations; however, the SKC passive monitor was slightly greater than the NIOSH recommendation. Pooled overall uncertainty for STEL evaluations for the monitors were: Assay Technology Model 541 +/- 18%; 3M +/- 16%; and SKC +/- 27%.

Air Pollutants, Occupational↗
PubMed2001

Comparative study of the effects of a progestogen-only pill containing desogestrel and an intrauterine contraceptive device in lactating women.

OBJECTIVE: To evaluate the effects of desogestrel 75 microg/day, as a progestogen-only pill compared with a copper-bearing intrauterine contraceptive device (IUCD) on lactation and to study the safety of both treatments in mothers and children. Transfer of etonogestrel to breast milk was studied in a subgroup of desogestrel users. The children were to be followed up until 2.5 years of age. DESIGN: An open, non-randomised, group-comparative study in lactating women. SETTING: University Hospital, Reykjavik, Iceland. PARTICIPANTS: A total of 83 lactating women; 42 received desogestrel and 41 had an IUCD inserted for seven consecutive treatment cycles of 28 days. METHODS: Evaluation visits were planned at baseline and at the end of treatment cycles 1, 4 and 7. The amount of breast milk was determined by weighing the infants before and after feeding, at baseline and after treatment cycles I and 4. Milk samples were obtained at the same time for constituent measurements. Safety was studied by structured medical examinations and by recording adverse experiences in mothers and children. RESULTS: There were no significant differences between the desogestrel and IUCD groups in composition and quantity of breast milk nor in growth and development of the children followed up to the age of 2.5 years. In the desogestrel group a slightly higher incidence of mild adverse experiences of a hormonal nature was reported among both mothers and infants. Of the children 82% were followed until 1.5 years of age and 50% until 2.5 years. CONCLUSION: The use of desogestrel 75 microg/day did not change the amount and composition of breast milk nor did it affect growth and development of the breastfed children. It appears to be a safe and effective contraceptive method for lactating women

Adult↗
PubMedDate not supplied

Metabonomics technologies and their applications in physiological monitoring, drug safety assessment and disease diagnosis.

In this review, metabonomics, a combination of data-rich analytical chemical measurements and chemometrics for profiling metabolism in complex systems, is described and its applications are reviewed. Metabonomics is typically carried out using biofluids or tissue samples. The relevance of the technique is reviewed in relation to other '-omics', and it is shown how the methods can be applied to physiological evaluation, drug safety assessment, characterization of genetically modified animal models of disease, diagnosis of human disease, and drug therapy monitoring. The different types of analytical data, mainly from nuclear magnetic resonance spectroscopy and mass spectrometry, are summarized. The outputs from a metabonomics study allow sample classification, for example according to phenotype, drug safety or disease diagnosis, and interpretation of the reasons for classification yields information on combination biomarkers of effect. Transcriptomic and metabonomic data is currently being further integrated into a holistic understanding of systems biology. An assessment of the possible future role and impact of metabonomics is presented.

Age Factors↗
PubMed2004

Microbiological and metal contamination of watercress in the Wellington region, New Zealand--2000 survey.

OBJECTIVES: To investigate potential microbiological and metal contamination of watercress and to assess the public health risks associated with harvesting and consumption of watercress. METHOD: During March and April 2000, samples were taken from 11 known or potential watercress collection sites in the Wellington region. Microbiological testing included bacterial counts for presumptive and faecal coliforms (watercress); total coliforms (growing water); and Escherichia coli (E. coli) and presence/absence tests for Campylobacter species (growing water and watercress). Watercress concentrations of a range of metals were also measured. RESULTS: All of the sites showed significant levels of E. coli in samples of both watercress and water. The E. coli levels in water were well above recommended freshwater recreational contact safety guidelines at most sites. Campylobacter was detected in the growing waters at all sites (80% of the samples) and in 11% of the watercress samples. Mean metal concentrations in watercress did not exceed the NZ Food Regulations (1984) levels at any of the sites. However, lead concentrations at the urban sites and one of the semi-urban sites would have exceeded the new Australia New Zealand Food Standards Code maximum levels (2003). CONCLUSIONS AND IMPLICATIONS: The consumption of raw watercress contaminated with enteric pathogens could potentially cause serious gastrointestinal illness (e.g. campylobacteriosis) and people gathering watercress could also be at risk of infection from contact with contaminated surface waters.

Campylobacter↗
PubMed1999

Microbiological quality and safety of ready-to-eat street-vended foods in Johannesburg, South Africa.

Fifty-one ready-to-eat street foods, 18 dishwater, and 18 surface swab samples were collected from six vendors in Johannesburg, South Africa. Food temperatures were recorded at the time of sampling. Standard methods were used to determine aerobic plate counts (APCs), spore counts (SCs), and Enterobacteriaceae counts (ECs) for food samples as well as coliform counts (CCs) for water and swab samples. In addition, Petrifilm Escherichia coli count (PC) plates were used for the enumeration of coliforms in food, water, and swab samples. The presence of selected foodborne pathogens in the food samples as well as the presence of nonpathogenic E. coli 1 (in food and water samples) was also tested for. Predominant colonies isolated from APC plates were characterized to the genus level. Holding temperatures for cooked meats and gravies ranged from 42.0 to 94.0 degrees C, and those for uncooked salads ranged from 29.0 to 39.0 degrees C. Mean APC values of 3.4 (+/-0.4) log CFU/g, 4.0 (+/-1.2) log CFU/ml, and 2.1 (+/-0.4) log CFU/25 cm2 were obtained for food, water, and swab samples, respectively. Mean SC values of 1.6 (+/-0.2) log CFU/g and 1.5 (+/-0.3) log CFU/25 cm2 were obtained for food and swab samples, respectively. A mean EC value of 2.0 (+/-0.4) log CFU/g for food samples and mean CC values of 2.5 (+/-0.3) log CFU/ml and 1.3 (+/-0.3) log CFU/25 cm2 for water and swab samples, respectively, were determined. Mean PC values of 1.6 (+/-0.1) log CFU/g, 1.9 (+/-0.6) log CFU/ml, and 1.4 (+/-0.4) log CFU/25 cm2 were determined for food, water, and swab samples, respectively. Bacillus cereus was detected in 22%, Clostridium perfringens in 16%, Salmonella spp. in 2%, and E. coli (non-O157:H+) in 2% of the 51 food samples. E. coli was found in 14 water samples (78%) and in 3 food samples (6%). Campylobacter spp., Listeria monocytogenes, Staphylococcus aureus, Vibrio cholerae, and Yersinia enterocolitica were also tested for in the food samples, but they were not detected. The 340 isolates obtained from APC plates for food, water, and swab samples were predominantly Bacillus spp., Micrococcus spp., and Staphylococcus spp. for all three sample types. It was concluded that the foods analyzed in this study were of acceptable quality and safety.

Colony Count, Microbial↗
PubMed2005

[Safety awareness of anticancer drug handling among Japanese nurses].

OBJECTIVES: The purpose of this study was to investigate Japanese nurses' awareness of the adverse effects of occupational exposure to anticancer drugs and safe handling, as well as their associations. METHODS: A self-rating questionnaire was mailed to 939 nurses in 107 university hospitals, 13 cancer-special hospitals, and 193 general hospitals with over 300 beds and at least five or more clinics in Japan. A total of 571 female nurses responded to the questionnaire. RESULTS: About 40% of the nurses were not at all aware of the potential adverse effects of occupational exposure to anticancer drugs. Eighty-eight percent of the nurses prepared anticancer drugs in the hospital wards; in most cases, nurses, not doctors or pharmacists, transported and administered such drugs to cancer patients. Regarding safety, 39% of the nurses took protective countermeasures against anticancer drugs; 15% paid special attention to the handling environment; 10% had guidelines for the handling of anticancer drugs; and, only 7% took countermeasures with body fluids or linen handling of cancer patients. Although 82% of the nurses were concerned about the potential health effects of occupational exposure, 75% or over did not know whether the exposure might affect their future health or progeny. Awareness of adverse effects was significantly related with precaution in anticancer drug handling, for which 95% of the nurses stated a desire for special education and training. CONCLUSIONS: Approximately 60% of Japanese nurses are aware of the risk of occupational exposure to anticancer drugs, but this might be an overestimate because of the sampling bias. Since only small numbers of nurses take sufficient safety precaution, programs for education and training for safe handling of anticancer drugs are crucial.

Adult↗
PubMed2006

Commentary on the British Thoracic Society guidelines for the investigation of unilateral pleural effusion in adults.

The publication of guidelines for the investigation of unilateral pleural effusion in adults by the British Thoracic Society has focused attention on this subject which, although comprising only a small proportion of laboratory workload, is a fairly common clinical problem. We critically reviewed the guidance applicable to clinical biochemistry laboratories and found a number of deficiencies. In particular, the need for anaerobic sample collection for pH measurement and preservation of samples for glucose assay is not mentioned and health and safety issues related to the handling of potentially infected fluids are also not considered. There are discrepancies between recommendations in the text and in the accompanying diagnostic algorithm, which require clarification. Measurement of total protein is an essential first step in the analysis of pleural fluid and will usually distinguish transudates from exudates. Measurement of lactate dehydrogenase activity is only required when total protein results are equivocal. There are practical difficulties with measurement of fluid pH as recommended in the guidelines and there is little evidence that such measurements are valuable. Similarly, there is little evidence to support the recommendation for measurement of complement in suspected rheumatoid effusions, and the recommendation for amylase isoenzyme studies if acute pancreatitis is a possibility is not practical. The different nature of pleural fluid demands a good understanding of the handling of these samples, the limitations of the analytical methods and the subsequent result interpretation by laboratory staff. We propose a modified diagnostic algorithm reflecting our criticisms of the original. Dialogue between the laboratory and local clinicians, possibly with the production of local guidelines, informed by these recommendations, should help optimize diagnostic management of patients with pleural effusion.

Adult↗
PubMed2003

The performance of laboratories analysing alpha-quartz in the Workplace Analysis Scheme for Proficiency (WASP).

The Workplace Analysis Scheme for Proficiency (WASP) is a proficiency testing (PT) scheme for the analysis of occupational hygiene and environmental air samples and is operated in the United Kingdom by the Health and Safety Laboratory (HSL) on behalf of the Health & Safety Executive (HSE). One of the 26 analytes available to laboratories is silica (alpha-quartz) on 25 mm Gelman GLA5000 filters. This paper investigates the performance of laboratories participating in the scheme since the HSL took over the production of the samples in 1998. The average relative standard deviation (RSD) of results obtained by a laboratory is 11.5%. This is reduced to 8.5% when the values from laboratories using indirect analytical methods are excluded. Laboratories using indirect analytical methods accounted for some of the most variable data. For the on-filter analytical methods the data suggested a relationship between relative standard deviation and loading that increased gradually from +/-4% at high analyte levels to +/-10-15% at low levels. The average precision estimate for the on-filter analytical methods was found to be 5.6% RSD for the infrared technique and 6.7% RSD for the X-ray diffraction technique. These figures compare favourably with those reported in the published HSE methods. No significant difference was found between the average result reported by laboratories using on-filter infrared (IR) analysis and the average result reported by laboratories using on-filter X-ray diffraction (XRD) analysis. An ANOVA analysis found the repeatability estimate was just as large as the 'between laboratory' variation for both the XRD and IR on-filter analysis techniques. When a limited number of 'realistic' samples were included in the scheme, XRD analysis was found to perform slightly better than IR analysis. The performance of laboratories in the WASP scheme compares very favourably with other published data from a PT scheme where indirect silica analytical methods are predominately used.

Air Pollutants, Occupational↗
PubMed2003

[Equipment for SARS control in patient care units and in units that process infected samples. 2003].

The information on severe acute respiratory syndrome (SARS) that has been gathered up to this point has made it possible to prepare recommendations concerning the equipment needed to protect health workers responsible for patient care and for processing potentially infected samples. Protecting such personnel is a key element in the strategy to control the spread of SARS. The needed equipment includes clothing; footwear; such protective devices as masks, safety glasses, and gloves; disinfectant solutions; laboratory equipment; and materials for obtaining and transporting samples. Prepared by the Western Pacific Regional Office of the World Health Organization, this list will help implement measures to contain the epidemic. The list gives the recommended quantities, specifications for the items, and possible alternatives for some items. This list of equipment is not exhaustive; it is intended to provide a small emergency supply for a period of 3 or 4 days for a single isolation unit with approximately 50 workers. To guarantee the availability of the equipment in the needed quantities, infection control authorities should take into account the number of isolation units needed and the length of time that containment measures will need to be in place. Adequate reserves should be available 24 hours a day, and plans should be made for rapid access to larger stocks in the event of a larger outbreak.

Communicable Diseases, Emerging↗
PubMed1990

Perspectives in medicine. Generalizability of homogenous samples in clinical trials.

Clinicians face a tremendous challenge in staying abreast of the medical literature. They must be particularly cautious to assess the safety and efficacy of new tests and treatments. Advances in research methodology have led to increasing use of homogenous or restricted samples. While this may improve the quality of the research design and reduce costs, there is a loss of generalizability. Often journal reports do not provide sufficient information so the clinician can decide whether the data and results reported are applicable to a patient population. This is particularly important to clinicians whose patients come predominantly from "special populations." Investigators, journal editors and clinicians need to increase their efforts to maximize considerations of generalizability in clinical trials.

Clinical Trials as Topic↗
PubMedDate not supplied

A national profile of patient safety in U.S. hospitals.

Measures based on routinely collected data would be useful to examine the epidemiology of patient safety. Extending previous work, we established the face and consensual validity of twenty Patient Safety Indicators (PSIs). We generated a national profile of patient safety by applying these PSIs to the HCUP Nationwide Inpatient Sample. The incidence of most nonobstetric PSIs increased with age and was higher among African Americans than among whites. The adjusted incidence of most PSIs was highest at urban teaching hospitals. The PSIs may be used in AHRQ's National Quality Report, while providers may use them to screen for preventable complications, target opportunities for improvement, and benchmark performance.

Health Care Surveys↗